WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Pristiq or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Pristiq is not approved for use in pediatric patients [ see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.4 ), and Patient Counseling Information ( 17.1 ) ].
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PRISTIQ SUMMARY
MEDICATION GUIDE
Pristiq is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O‑desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive, generalized anxiety, social anxiety and panic disorders.
Pristiq, a selective serotonin and norepinephrine reuptake inhibitor (SNRI), is indicated for the treatment of major depressive disorder (MDD) [ see Clinical Studies (14) and Dosage and Administration (2.1) ]. The efficacy of Pristiq has been established in four 8-week, placebo-controlled studies of outpatients who met DSM-IV criteria for major depressive disorder.
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation.
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NEWS HIGHLIGHTSMedia Articles Related to Pristiq (Desvenlafaxine)
Untreated, Mild May Become Major Depression (HealthDay)
Source: Y! Health News Search RSS Feed [2010.02.04]
HealthDay - THURSDAY, Feb. 4 (HealthDay News) -- For many people whose depression
goes untreated, symptoms persist and worsen over time, eventually leading
to a diagnosis of major depression, according to new research.
Link Between Excessive Internet Use And Depression
Source: Depression News From Medical News Today [2010.02.03]
People who spend a lot of time browsing the net are more likely to show depressive symptoms, according to the first large-scale study of its kind in the West by University of Leeds psychologists. Researchers found striking evidence that some users have developed a compulsive internet habit, whereby they replace real-life social interaction with online chat rooms and social networking sites...
Internet Addicts More Prone to Depression (HealthDay)
Source: Y! Health Depression News [2010.02.03]
HealthDay - WEDNESDAY, Feb. 3 (HealthDay News) -- Internet addicts who devote much
of their lives to browsing the Web are more likely to show signs of
depression, British researchers have found.
Internet Addicts More Prone to Depression
Source: MedicineNet Depression Specialty [2010.02.03]
Title: Internet Addicts More Prone to Depression
Category: Health News
Created: 2/3/2010 8:10:00 AM
Last Editorial Review: 2/3/2010
Alcoholics Anonymous Meetings May Reduce Depression Symptoms
Source: Alcohol / Addiction / Illegal Drugs News From Medical News Today [2010.01.29]
One of many reasons that attendance at Alcoholics Anonymous (AA) meetings helps people with alcohol use disorders stay sober appears to be alleviation of depression. A team of researchers has found that study participants who attended AA meetings more frequently had fewer symptoms of depression - along with less drinking - than did those with less AA participation...
Published Studies Related to Pristiq (Desvenlafaxine)
Desvenlafaxine 50 and 100 mg/d in the treatment of major depressive disorder: an 8-week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial and a post hoc pooled analysis of three studies. [2009.06]
BACKGROUND: Major depressive disorder (MDD) is a common, chronic illness associated with substantial disability and economic burden. Although a number of effective antidepressants are available, the need for new medications that are effective and well tolerated remains. OBJECTIVE: The aim of this study was to compare the efficacy and tolerability of fixed-dose desvenlafaxine 50 and 100 mg/d with placebo for MDD. A post hoc pooled analysis was conducted to evaluate this study in the context of all similarly designed, completed studies with the 2 doses... CONCLUSIONS: The current study failed to meet its primary efficacy end point based on the a priori analysis plan. Desvenlafaxine was generally well tolerated. A post hoc pooled analysis of this trial and 2 previously published trials with both desvenlafaxine 50 and 100 mg/d found both doses to be effective for MDD compared with placebo. ClinicalTrials.gov Identifier: 00384033.
An integrated analysis of the safety and tolerability of desvenlafaxine compared with placebo in the treatment of major depressive disorder. [2009.04]
INTRODUCTION: The safety and tolerability profiles of antidepressants can often influence the treatment choices of clinicians treating major depressive disorder. The purpose of this investigation was to characterize the safety and tolerability of desvenlafaxine (administered as desvenlafaxine succinate) in treating depression... CONCLUSION: Desvenlafaxine in the treatment of major depressive disorder exhibited a safety and tolerability profile generally consistent with the serotonin-norepinephrine reuptake inhibitor class. The most common adverse event was transient nausea. At the recommended therapeutic dose of 50 mg/day, discontinuation due to adverse events was similar to placebo.
Desvenlafaxine for the treatment of vasomotor symptoms associated with menopause: a double-blind, randomized, placebo-controlled trial of efficacy and safety. [2009.03]
OBJECTIVE: The objective of the study was to assess the efficacy and safety of desvenlafaxine (administered as desvenlafaxine succinate) for the treatment of vasomotor symptoms... CONCLUSION: Desvenlafaxine is an effective treatment for menopausal HFs.
Desvenlafaxine for the treatment of vasomotor symptoms associated with menopause: a double-blind, randomized, placebo-controlled trial of efficacy and safety. [2009.01.22]
OBJECTIVE: The objective of the study was to assess the efficacy and safety of desvenlafaxine (administered as desvenlafaxine succinate) for the treatment of vasomotor symptoms... CONCLUSION: Desvenlafaxine is an effective treatment for menopausal HFs.
Efficacy, safety, and tolerability of fixed-dose desvenlafaxine 50 and 100 mg/day for major depressive disorder in a placebo-controlled trial. [2008.09]
The objective of this study was to assess the efficacy, safety, and tolerability of desvenlafaxine (administered as desvenlafaxine succinate) 50 and 100 mg/day for major depressive disorder (MDD). A multicenter, randomized, double-blind, placebo-controlled trial was conducted in Europe and South Africa...
Clinical Trials Related to Pristiq (Desvenlafaxine)
Desvenlafaxine Succinate (DVS) for Major Depressive Disorder (MDD) in Midlife Men and Women [Recruiting]
The main objective of this study is to characterize a range of brain activation symptoms
associated with depression and response to treatment in midlife men and women with MDD,
using MRI and functional MRI. Moreover, in the female sub-group, the investigators will
examine whether these brain activation symptoms are related to menopausal symptoms (i. e.,
hot flashes and night sweats). Also, assessing brain activation before and after the
treatment might help to uncover some mechanisms associated with the pathophysiology of
depression and menopause.
Study Evaluating the Safety, Tolerability and Pharmacokinetics of Desvenlafaxine Succinate SR in Healthy Chinese Male and Females [Not yet recruiting]
The main purpose of this study is to evaluate the safety and tolerability of desvenlafaxine
succinate SR in healthy male and female Chinese subjects. The amount of drug in the body and
the effects of the drug will also be evaluated.
Study Evaluating Long-Term Safety of Desvenlafaxine Succinate Sustained Release With Japanese Adult Subjects in MDD [Recruiting]
The primary objective of this study is to evaluate the long-term safety of desvenlafaxine
succinate sustained release tablets during 10-month open-label treatment of Japanese
subjects with MDD.
The secondary objective is to evaluate the long-term response of subjects receiving
desvenlafaxine succinate sustained release tablets by clinical global evaluation, general
well-being and absence of symptoms.
Randomized Withdrawal Study of Desvenlafaxine Succinate Sustained Release in Outpatients With Major Depressive Disorder [Recruiting]
The primary purpose of this study is to compare the long-term efficacy and safety of
desvenlafaxine succinate sustained release versus placebo in adults with Major Depressive
Disorder, using a randomized withdrawal design. Randomized withdrawal means that after
receiving desvenlafaxine succinate sustained release for a predetermined period of time,
subjects will be selected by chance to either continue receiving the study drug or to be
withdrawn from the study drug and receive placebo for the remainder of their participation
in the trial. Subjects will not know to which group they have been assigned.
Study Evaluating Desvenlafaxine Succinate Sustained Release in Outpatients With Major Depressive Disorder [Not yet recruiting]
This is a multicenter study to assess the health and well-being in subjects who are
outpatients with major depressive disorder that take desvenlafaxine succinate sustained
release or placebo for 12 weeks.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 2 ratings/reviews, Pristiq has an overall score of 8.50. The effectiveness score is 8 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
| | Pristiq review by 52 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | Depression |
| Dosage & duration: | | 50mg taken once daily for the period of I have been taking this drug for 6 month |
| Other conditions: | | anxiety |
| Other drugs taken: | | xanax | | |
Reported Results |
| Benefits: | | This is an NSRI, different from an SSRI because it works on more than one brain chemical. When an SSRI is ineffective or a patient finds that after a period of time a working drug stops working and symptoms of depression return they may be advised to try an NSRI. This was the case with me. I have been treated for my depression for years and had done extremely well for periods of time on several different drugs at different times. Moving from one to the next as I bottomed out on each. Celexa and Lexapro being the most recent. When Lexapro let me down after a couple of years I was advised to try Pristiq which was just released only a few months before my doctor suggested it. I was extremely hesitant as I did not want to go through another adjustment period of sleeplessness, headaches, possible weight gain, sexual issues, etc. You know the drill if you have taken drugs for deperession. So I chose to stay on my Lexapro and be depressed, hoping that it would start working again at a higher dose. Wrong. Getting to the end of my rope with my depression I finally decided to bite the bullet and try the Prestiq. My depression disappeared within 3 weeks leaving me feeling better than I had in months. I began smiling again and fully functioning doing the things I enjoy and had let slide. My sense of well being and hopefulness for the future returned. |
| Side effects: | | Honestly, none for me. I sleep, did not gain an ounce, in fact I lost a small amount of weight even though I did not need to, no sexual side effect at all! Only thing that was tough was waiting for the dosage level to become theraputic in my system, which as I mentioned took about 3 weeks. |
| Comments: | | I was instructed to continue on the Lexapro at a lower dose for one week. At the 2nd week add my dose of Pristiq to the lower dose of Lexapro, at the 3rd week drop the Lexapro completely and continue on my dose of Pristiq. This was done while staying in contact with my prescribing doctor. Now I take 1 50mg tablet everyday of Pristiq, and am doing very well. |
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| | Pristiq review by 35 year old male patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Moderately Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | Depression |
| Dosage & duration: | | 100mg taken once a day for the period of 6 months |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | The drug helped to lift me out of the worst part of the depression, but it's not a complete cure. |
| Side effects: | | Nausea that varied from day to day. Some days were almost unnoticeable while others were almost intolerable. Didn't get any better the longer I took the meds.
Constipation and Diaohhrea. Swings between the two which is really annoying. |
| Comments: | | No medication is a complete cure for depression. I had tried at least half a dozen other medications before we settled on this one. |
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Page last updated: 2010-02-04
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